MAUDE Adverse Event Report: EXACTECH, INC. CC TIBIAL INSERT SZ 4, 13MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	208-24-13
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient underwent an initial total knee arthroplasty with a competitor's device.Subsequently, the patient developed an infection and was revised to exactech device.After being converted to exactech devices, the patient then developed pain and poly wear resulting in another revision.No further information available.
Additional Manufacturer Narrative
D10: 02-012-45-4030 - lgc tibial fit tray cem sz 4f / 3t (b)(6).200-02-35 - three peg patella 35mm (b)(6).201-24-13 - tibial insert trial sz 4 13 mm unassigned.201-46-10 - holding pin headless 3" (4 pk) (b)(6).204-34-04 - fluted stem extension 40l x 14 mm (b)(6).204-34-08 - fluted stem extension 80l x 14 mm (b)(6).208-01-04 - cc femoral sz 4 (b)(6).208-05-04 - cc distal fem augment sz 4, 5mm (b)(6).208-05-04 - cc distal fem augment sz 4, 5mm (b)(6).208-07-04 - cc posterior fem augment sz 4, 5mm (b)(6).208-07-04 - cc posterior fem augment sz 4, 5mm (b)(6).208-09-05 - cc stem ext adaptor 5 degree (b)(6).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

• Brand Name: CC TIBIAL INSERT SZ 4, 13MM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH; 2320 nw 66 ct; gainesville FL 32653
• Manufacturer Contact: geoff gannon ; 2320 nw 66 ct; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 23866650
• Report Number: 1038671-2025-03597
• Device Sequence Number: 4438013
• Product Code: JWH
• UDI-Device Identifier: 10885862054340
• UDI-Public: 10885862054340
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954208
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: 208-24-13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 12/22/2025
• Date Device Manufactured: 03/18/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown